Regulatory Recon: White House Plans Zika Summit, Senate Democrats Propose Biomedical Research Funding Bill (4 March 2016)

Posted 04 March 2016 | By Michael Mezher 

Regulatory Recon: White House Plans Zika Summit, Senate Democrats Propose Biomedical Research Funding Bill (4 March 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Senate Democrats Call for FDA, NIH Funding Boost as Other Bills Emerge (Focus) (WSJ-$) (BioCentury) (SCRIP-$)
  • Senator Proposes Priority Reviews for Some Generics, New Voucher Program (Focus) (SCRIP-$) (FDA Law Blog)
  • White House and states to craft Zika attack plan at summit (Reuters)
  • Fighting Drug Addiction With Drugs Works, but Only if Doctors Sign On (NYTimes)
  • Large Genetic Studies Support Role For Triglycerides In Cardiovascular Disease (CardioBrief)
  • US free vaccine program tied to reduced disparities for kids (Reuters)
  • Generic drug ETF ailing despite political focus on high drug prices (Reuters)
  • DNA App Store (MIT Technology Review)
  • Genetically engineered immune cells are saving the lives of cancer patients (MIT Technology Review)
  • Amid Lobbying Surge, Kentucky State Senate Passes Drug Substitution Bill (KYCIR)

In Focus: International

  • Grand Convergence: Aligning Technologies & Realities in Global Health (PLOS)
  • New EU IVD Regulatory Reality: Bumpy Ride or Smooth Sailing? (Clinica-$)
  • Sanofi plots accelerated path to Zika vaccine (Reuters)
  • South African state-owned drug firm seeks anti-retroviral supplies (Reuters)
  • Indian CEOs On Plugging Quality Gaps: Yes We Can (PharmAsiaNews-$)
  • Novel veterinary medicines – how to make use of stem cells and monoclonal antibodies (EMA) (Scientific Guidelines: mAbs, stem cells)
  • First Chinese-manufactured biologic dosed in an EU clinical trial (BioPharma-Reporter)

US: Pharmaceuticals & Biotechnology

  • Novo Nordisk says Victoza helps lower heart risks (Reuters)
  • Duchenne Muscular Dystrophy Drugs Face Tough Path to Approval (Thomson Reuters)
  • Guidance: Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity (FDA)
  • The newest cancer therapies don't work on everyone. Now, doctors have a clue why (STAT)
  • Prolonged aspirin use tied to reduced colon cancer risk (Reuters)
  • Look Beyond The Headlines: Tackling Ever-Present Challenge Of Antimicrobial Resistance (LifeSciVC)
  • Rare Disease Goalposts: A Conundrum For Pharma, FDA (SCRIP-$)
  • Edward Lammer, Doctor Who Linked Acne Drug to Birth Defects, Dies at 62 (NYTimes)
  • ADHD drugs linked to low bone density in kids (PharmaLetter-$)
  • How Sharing Health Data Benefits Rare Disease Patients (Geeks Talk Clinical)
  • FDA Wants To Study Whether Animated Prescription Drug Ads Are Memorable For The Right Reasons (Forbes)
  • Beyond biosimilarity (GaBI)
  • Biosimilars Education: Oncobiologics/Premier Deal Aims To Boost Adoption, Data Collection (Pink Sheet-$)
  • Mathai Mammen, The Anti-Shkreli, Brings Heart And A Touch Of Vagelos To Merck R&D (Fobres)
  • Combating Antimicrobial Resistance in 2015 (CSIS)
  • How effective is Twitter to share cancer clinical trial information and recruit (MNT)
  • CROs need to educate consumers on clinical trials (Outsourcing-Pharma)
  • Almost half of US physicians will prescribe more biosimilars, according to survey (Pharmafile)
  • Industry work on rare diseases continues to bear fruit (EP Vantage)
  • Nanotech accelerates Precision Medicine evolution: F&S (BioSpectrum)
  • 'Rapid Kill' Antibiotic Awaits US Data For Blanket Decolonization Prior To Surgery (SCRIP-$)

US: Pharmaceuticals & Biotechnology: Clinical Study Results, Filings & Designations

  • Novel Small-Molecule Antiviral Compound Protects Against Ebola Virus (ICT)
  • Bio-Path Holdings Announces Completion of the Safety Segment of the Phase II Clinical Trial of BP1001 in Acute Myeloid Leukemia (Press)
  • First patient dosed in BAX 826 haemophilia A Phase I trial (EPR) (Press)
  • Oral OTEZLA (apremilast) Data from Open-Label Phase of ESTEEM and LIBERATE Trials to Be Presented at American Academy of Dermatology Congress (Press)
  • Sanofi Genzyme Presents Results from Phase 1/2 Study of Investigational Second-Generation Therapy for Pompe Disease (Press)
  • GSK's Benlysta slows organ damage in lupus patients, study finds (PharmaTimes)

US: Medical Devices

  • Refurbished Medical Devices: FDA Wants to Hear More From Industry (Focus) (Gray Sheet-$) (FDA)
  • Industry, FDA Outline Costs Of New MDUFA Proposals; Quality Management A Strong Focus (Gray Sheet-$)
  • FDA's Role In Genetic Test Reports Debated At Public Meeting (Gray Sheet-$) (Focus)
  • JAMA study finds popular app for measuring blood pressure is inaccurate (Fierce) (JAMA)
  • ISO 13485:2016 What are the Changes About? (GxP Lifeline) (Focus)
  • Toward diagnosing diseases such as cancer in their earliest stages (MNT)
  • Boston Scientific releases ureteral stent tracker app (MassDevice)
  • Gore wins FDA nod for Excluder stent graft (MassDevice)
  • FDA approves Medtronic's Specify SureScan MRI-safe neurostim leads (MassDevice)
  • FDA clears Zimmer Biomet's elbow-shoulder combo (MassDevice)
  • Novocure wins reimbursement from Humana for Optune brain cancer device (MassDevice)
  • Dräger Evita V500 and Babylog VN500 Ventilators – Recall Expanded (FDA)
  • Stryker Receives FDA Clearance for Tritanium PL Posterior Lumbar Cage (Press)

US: Assorted & Government

  • Shut out for decades, veterans slowly gaining access to innovative cancer treatments (STAT)
  • US senator calls for GAO probe to protect babies born drug-dependent (Reuters)
  • Why Trump Is Wrong On Drug Prices (Forbes) (NYTimes)
  • Obama Says Enrollment in Affordable Care Act Reaches 20 Million (NYTimes)
  • Can the United States Use Mortgage-Like Loans to Pay for High Cost Drugs? (Harvard Bill of Health)
  • 15,000 Flint children exposed to lead will get special Medicaid coverage (Washington Post)

Upcoming Meetings & Events


  • European Regulatory Roundup: EMA Proposes Major Changes to Risk Management (3 March 2016) (Focus)
  • Major increase in EU's contribution to Global Fund (PharmaLetter-$) (Global Fund)
  • New Guidance Spells Out How to Comply With EMA's Clinical Data Publication Policy (Focus) (SCRIP-$)
  • Country Reports in the European Semester 2016 (EFPIA)
  • Meeting of the Competent Authorities for Tissues and Cells, Minutes (European Commission)
  • ANSM continues investigations into Bial clinical trial death (PharmaLetter-$)
  • EU seen approving weed-killer ingredient glyphosate amid cancer row (Reuters)
  • Perception and knowledge of generics in Portugal (GaBI)
  • Kick-off meeting of the third HTA Joint Action: 3 March 2016 (European Commission)
  • Xtant Medical wins CE Marks for Aranax, Irix-A spine devices (MassDevice)


  • Factors To Consider Before Making Any Patent Moves In Japan (Law360-$)
  • Pfizer Japan Preps For Local Mergers, Calls For Policy Debate (PharmAsiaNews-$)


  • Spurious drugs survey data evaluation reaches final stages of testing and compilation (PharmaBiz)
  • CDSCO Expert Committee Recommends Approval For BMS Opdivo Cancer Treatment (24 Inight)
  • India's health protection gap among biggest in Asia: Report (Economic Times)
  • Mah FDA stresses on need to increase cooperation between industry & FDA to curb counterfeit drugs (PharmaBiz)
  • KSRPA objects to health ministry's proposal to hike pharmacy outlet sales license fee from Rs.20 to Rs.1,000 (PharmaBiz)
  • 126 drugs cheaper by over 40% as govt fixes ceiling (Economic Times)

Zika Virus

  • Google to throw software engineering into the Zika virus fight (LA Times)
  • Questions grow about Zika's risk to future pregnancy (Reuters)
  • Research indicates another common mosquito may be able to carry Zika (Reuters)

General Health & Other Interesting Articles

  • Rare superbug outbreak in Wisconsin is blamed for 18 deaths (STAT)
  • Genital talc boosts ovarian cancer risk in study (Reuters)
  • Study Finds Surprising Benefit of Viral DNA: Fighting Other Viruses (NYTimes)
  • Apple Watch study aims to enroll 40,000 to uncover mysteries of how we sleep (Washington Post)
  • Here's how one journalist discovered the rush to robotic surgery was ahead of the evidence (AHCJ)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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